BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-5100CLX CLINICAL 5PK US

    MDR report key: 17479258 · Received August 8, 2023

    Report

    Report Number
    2032227-2023-251051
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    July 17, 2023
    Report Date
    December 1, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REVIEW OF THE EVENT SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803.

    Additional Manufacturer Narrative · 0

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    AS PER THE INFORMATION REPORTED BY THE CUSTOMER INSULIN DELIVERY WAS NOT SUSPENDED. HENCE AS PER THE REPORTABILITY DECISION TREE THE CASE WAS NOT REPORTABLE AND NOT REQUIRED FOR REPORTING.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED INSULIN PUMP KEEPS SHOWING LOW BG (BLOOD GLUCOSE) VALUE WAS 512 MG/DL. CUSTOMER REPORTED SENSOR WAS READING LOW AND CUSTOMER ATE CARBS. CUSTOMER WAS REPORTED INSULIN DELIVERY WAS NOT SUSPENDED DUE TO SG (SENSOR GLUCOSE) VS BG (BLOOD GLUCOSE) DIFFERENCE. SG VALUE FROM REPORTED EVENT WAS 50.00 MG/DL AND BG VALUE FROM REPORTED EVENT WAS 512.00 MG/DL AND DIFFERENCE IN VALUE BETWEEN SG AND BG WAS 462.00 AND DIFFERENCE BETWEEN SG AND BG NOT WITHIN THE TARGET RANGE. CUSTOMER DID NOT CONSUMED MEDICATION SUCH AS ACETAMINOPHEN, PARACETAMOL, OR HYDROXYUREA (ALSO KNOWN AS HYDROXYCARBAMIDE). INSULIN PUMP WAS USED WITHIN 48 HOURS OF THE REPORTED HIGH BG EVENT AND AUTO MODE/SMARTGUARD FEATURE ACTIVE AT TIME OF HIGH BG EVENT. TROUBLESHOOTING WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS UNKNOWN IF THE CUSTOMER WILL CONTINUE TO USE OF THE DEVICE AND THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480941 SENSOR MMT-5100CLX CLINICAL 5PK US SENSOR, GLUCOSE, INVASIVE , NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-5100CLX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other